CCRP Certified Clinical Research Professional (CCRP) Questions and Answers

FormFDA 1572is the investigator’s signed agreement to follow regulations.

21 CFR 312.53(c)(1)(vi)(c):Requires investigators to sign Form 1572, committing to conduct trials in accordance withFDA regulations (21 CFR 50 & 56).

The form includes commitments to personally supervise, obtain informed consent, maintain records, and permit FDA inspections.

It does not include financial disclosures (covered under21 CFR 54) or preclinical data (in theIB).

TheFDA record retention requirementfor investigational drug studies is clearly outlined in21 CFR 312.57(c)and21 CFR 312.62(c).

21 CFR 312.57(c):“A sponsor shall retain the records and reports… for2 years after a marketing application is approvedfor the drug; or, if an application is not approved, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.”

21 CFR 312.62(c):Investigators also must retain study-related records for2 years following the date a marketing application is approvedor 2 years after the investigation is discontinued.

This requirement ensures FDA can audit investigational product data even after approval to confirm compliance and verify trial results. Longer retention (e.g., 15 years) may be institutional or sponsor policy but is not mandated by federal law.

Thus, the correct answer isA (2 years).

For non–sponsor investigators, responsibilities are limited tosite-level conduct and product accountability.

ICH E6(R2) 4.6.1:“Responsibility for investigational product(s) accountability at the trial site rests with the investigator/institution.”

21 CFR 312.61:Requires the investigator to administer investigational drugs only to subjects under their supervision and maintain control.

Other responsibilities listed belong tosponsors:

A: Reporting SAEs to FDA is a sponsor duty (investigators report to sponsor, not directly to FDA).

B: Monitoring at all sites is a sponsor responsibility.

C: Disseminating safety updates is a sponsor’s role.

Correct answer:D (Maintaining control of IP).

AnIndependent Data Monitoring Committee (IDMC or DSMB)is a group of independent experts established to review accumulating safety and efficacy data during a trial. Their main role is to ensure subject protection and trial integrity.

ICH E6(R2) 5.5.1:“The sponsor may consider establishing anindependent data-monitoring committee (IDMC)to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.”

Thus, DSMBs/IDMCsdo not perform trial approvals (A),do not design trials (C), anddo not select investigators (D). Their authority is strictly advisory, providing recommendations to sponsors about safety and whether continuation of the study is ethically justified. The sponsor makes the final decision, but DSMB recommendations are highly influential.

Therefore, the correct answer isB (Recommendations to stop a trial).

21 CFR 56.109(a):IRB must review and approve any protocol amendments before implementation.

ICH E6(R2) 4.5.2:Changes affecting subjects (e.g., genomic testing) require IRB/IEC approval and updated consent.

Thus, site must first obtainIRB approval for revised protocol and ICF.

ICH E6(R2) 4.8.10(n):Consent must include explanation about confidentiality and possible publication.

If not included, specificsubject consentmust be obtained before publishing identifiable results.

Thus, subject’s explicit permission is required.

21 CFR 812.7:Prohibits promotion of investigational devices or claiming safety/effectiveness until FDA approval is granted.

Investigational devices may only be used in clinical trials, not marketed.

Thus, promotion during an IDE study is anFDA violation.

This is adrug/device accountability calculation question, testing compliance with investigational product tracking.

The subject was instructed to perform4 glucose checks per day.

Over10 days, that equals40 tests (4 × 10 = 40).

Each test requires1 strip, so40 strips used.

Subject was given45 strips, leaving5 unusedafter 10 days.

Investigators are responsible for maintaining accurate device/product accountability.

ICH E6(R2) 4.6.3:“The investigator/institution should maintain records of the product’s delivery to the trial site, the inventory, the use by each subject, and the return to the sponsor or alternative disposition.”

This ensures monitoring can confirm that product/device use aligns with the protocol and subject adherence.

Thus, the correct answer isB (5 unused test strips).

ICH E6(R2) 4.6.1:The investigator is responsible for investigational product accountability at the site.

21 CFR 312.61:Investigators must administer the investigational drug only to subjects under their supervision.

The IRB maintains meeting minutes (A), preclinical studies are sponsor tasks (B), and financial interest documentation (C) is covered under sponsor reporting. Thus,D is correct.

The IB must be updatedas new significant safety information emerges.

ICH E6(R2) 7.3:“The sponsor should revise the IB as soon as new, significant information becomes available.”

ICH E2A:Requires sponsors to reportSuspected Unexpected Serious Adverse Reactions (SUSARs)in expedited reports and include them inIB updates or addenda.

A SUSAR report (B) represents new, unexpected, and serious safety information not previously documented, and therefore warrants inclusion as anIB addendumuntil the IB is formally updated.

Revised consent forms (A) are submitted to IRBs, not IBs. Site-specific SAE reports (C) remain at site/sponsor level, not in the IB. Product monograph updates (D) apply to approved products, not investigational ones.

Thus, the correct answer isB (SUSAR report).

Upon study closure, investigators must maintain documentation that allows subject data to be linked back if necessary. TheSubject Identification Code Listis a key essential document for ensuring traceability while maintaining confidentiality.

ICH E6(R2) 8.3.21:“Subject Identification Code List — A list of all subjects randomized to trial numbers, allowing investigator to identify each subject in case follow-up is required. This list should be kept in a confidential manner and retained for the maximum retention period.”

ICH E6(R2) 8.4:Essential documents for investigators include items needed for subject identification, protocol compliance, and trial closure.

Other listed documents (randomization list, monitoring report, audit certificate) are maintained by the sponsor, not the investigator. Thesubject code listensures that in the event of a safety issue, regulatory authority queries, or subject withdrawal, the investigator can trace back records.

Thus, the correct answer isB (Completed Subject Identification Code List).

Belmont Report:“Respect for Persons” incorporates two ethical convictions: treating individuals as autonomous agents and protecting those with diminished autonomy (e.g., prisoners).

Prisoners require special safeguards because of restricted liberty and potential coercion.

21 CFR 312.32(c)(1)(ii):Sponsors must notifyall participating investigatorsof any serious and unexpected suspected adverse reactions.

Investigators then inform IRBs and subjects as appropriate.

The investigator holds ultimate responsibility for all data reported.

ICH E6(R2) 4.9.1:“The investigator is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor on the CRFs and all required reports.”

Monitors (D) verify data accuracy but are not responsible for data quality. Quality specialists (B) and IRB staff (C) have no role in data entry.

Correct answer:A (The clinical investigator).

Investigators must formally close out a trial with the IRB/IEC.

ICH E6(R2) 4.13.2:“Upon completion of the trial, the investigator/institution should provide the IRB/IEC with a summary of the trial’s outcome.”

21 CFR 312.66:Reinforces investigator’s duty to keep IRB informed throughout study lifecycle.

This applies regardless of whether outcomes were positive, negative, or inconclusive. IRBs are not concerned with sponsor payments (B) or publications (D).

Thus, the correct answer isA (Provide final report to IRB/IEC).

Therisk-benefit ratiois a core responsibility of the IRB/IEC.

21 CFR 56.111(a)(2):“Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.”

ICH E6(R2) 3.1.2:IRB/IEC must safeguard rights, safety, and well-being of subjects, with special attention to risk-benefit evaluation.

Investigators (A) provide medical judgment but do not formally approve the risk-benefit balance. Sponsors (D) design studies but must submit to IRB for independent review. Legal counsel (C) is not part of the scientific/ethical evaluation.

Thus,IRB/IEC is directly responsible for approving the risk-benefit ratio.

ICH E6(R2) 3.1.2 & FDA Recruitment Guidance (1998):Recruitment materials must be reviewed by IRB to ensure no coercion or misleading claims.

CRFs and storage plans are sponsor/site tools, not IRB-reviewed documents.

Before an investigator can commit to conducting a trial, they must review thestudy protocol.

ICH E6(R2) 4.5.1:The investigator should conduct the trial in compliance with theprotocol approved by the IRB/IEC and sponsor.

ICH E6(R2) 4.2.3:The investigator should be thoroughly familiar with the appropriate use of the investigational product as described in the investigator’s brochure and the current approved protocol.

Although resources, training, and equipment are important, the fundamental step is provision of theprotocol, which forms the legal and ethical framework for study conduct. No trial agreement can be finalized until both parties agree on theprotocol details.

Sponsors must reportserious, unexpected, and suspected adverse reactions (SUSARs)to the FDA.

21 CFR 312.32(c)(2):“Any adverse experience associated with the use of the drug that is bothserious and unexpectedshall be reported…as soon as possible but no later than 7 calendar daysafter the sponsor’s initial receipt of the information, if it is fatal or life-threatening.”

ICH E2A 4.2:Requires expedited reporting oflife-threatening or fatal SUSARswithin 7 days.

Among the options, only (C) —death from arrhythmias not previously identified in the Investigator’s Brochure and suspected to be drug-related— meets the definition of a SUSAR requiring7-day expedited reporting. Events already listed in the IB (A, D) or unrelated to the drug (B) do not trigger expedited reporting.

Thus, the correct answer isC.

Theinformed consent processmust include all basic elements listed in federal regulations.

21 CFR 50.25(a)(4):Requires “a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.”

ICH E6(R2) 4.8.10(c):Mirrors this, requiring subjects to be informed of alternatives to participation, including available standard treatments.

This ensures the ethical principle ofRespect for Persons(Belmont Report), giving subjects the autonomy to choose among reasonable medical options.

Incorrect options:

A: Contact information must be provided, but it is for the investigator (or IRB), not sponsor.

B: Financial disclosures may be required for IRB review, not subject-facing.

C: Subjects do receive a copy, but it is not a required consentelementin regulations.

Correct answer:D.

21 CFR 812.35(a)(2):Allows deviation without prior approval only to eliminate immediate hazards.

Before applying broadly,IRB approvalmust be obtained.

ICH E6(R2) 5.16:Sponsors must implement ongoing safety evaluation, including expedited and periodic reporting.FDA and IRB review but do not conduct active monitoring.

Serious adverse events are subject to expedited reporting requirements.

ICH E2A 3.2.2:“Fatal or life-threatening unexpected ADRs should be reported as soon as possible but no later than7 calendar daysafter first knowledge.”

ICH E2A 3.2.3:Other serious unexpected events must be reported within 15 days.

Thus, the 7-day rule applies tolife-threatening and unexpected events(as in this case).

Correct answer:B (7 days).

Source data areoriginal records where data are first recorded.

ICH E6(R2) 1.51:Defines source data as “all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.”

Since subjects directly enter responses into the EDC, theEDC record itself is the original source document. EMRs (B, C) and printouts (D) are secondary records.

Correct answer:A (The EDC record).

Monitors verify compliance with protocol, sponsor SOPs, GCP, and regulations.

ICH E6(R2) 5.18.4:Outlines monitor responsibilities, including verifying informed consent, protocol compliance, investigational product accountability, and adherence to sponsor SOPs.

Monitors must also be familiar with subject-facing documents (A) and storage requirements for investigational product (B).

However,IRB/IEC requirements for reporting to regulatory authoritiesare outside a monitor’s scope. That responsibility lies with investigators and IRBs under21 CFR 56.108(b).

Thus, the correct answer isD.

Investigators must provideevidence of qualificationsto conduct the study.

ICH E6(R2) 4.1.1:“The investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial.”

ICH E6(R2) 8.2.10:Essential documents include thecurriculum vitae (CV)or other documents evidencing investigator qualifications, submitted to both sponsor and IRB/IEC.

Proof of citizenship (A) and letters of recommendation (B) are irrelevant. A copy of a medical license (D) may be provided but isnot specifically requiredby ICH. The CV is the universally required document.

Thus, the correct answer isC (Curriculum vitae).

Phase classification is based on study objectives, not just subject numbers.

Phase I:Focuses on safety, pharmacokinetics, dose-ranging, usually in healthy volunteers or small patient groups.

Phase II:Evaluateseffectiveness in patients with the conditionand monitors common short-term side effects.

Phase III:Confirms effectiveness in larger populations, compares to standard therapy, gathers more safety data.

Phase IV:Post-marketing studies exploring new indications, long-term safety, or special populations.

The given study aims toevaluate effectiveness and common short-term side effectsin 30 arthritis patients, which clearly aligns withPhase IIobjectives. It is not exploratory safety (Phase I), not confirmatory comparative (Phase III), nor post-marketing (Phase IV).

Thus, the correct answer isB (Phase II).

Outsourcing does not shift ultimate responsibility away from the sponsor. Exact extract:

ICH E6(R2) 5.2.1: “A sponsor may transfer any or all of the sponsor’s trial-related duties… to a CRO,but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.”Hence, D is correct.

Record retention requirements ensure regulatory access to data even after development is discontinued.

21 CFR 312.62(c):“An investigator shall retain records… for2 years after the date a marketing application is withdrawn or discontinuedand FDA is notified.”

In this case, development was terminated15 May 2019. Therefore, the 2-year clock starts at discontinuation. Two years later is15 May 2021, but FDA requires records to be maintaineduntil afterthe 2-year period ends. Theearliest permissible destruction date is 16 May 2022 (C).

Options A and B are premature; D (2034) is far beyond requirements.

Thus, the correct answer isC (16 May 2022).

India has aligned national regulations with ICH-GCP.

DCGI/ICMR Guidelines (India):Explicitly adopt ICH E6(R2) as part of its Good Clinical Practice standards.China and Brazil are harmonizing, but full official adoption is noted in India.

When a physician investigates amedical device for a new use (off-label indication), FDA regulations classify this as aSignificant Risk Device Study, requiring anInvestigational Device Exemption (IDE)in addition to IRB approval.

21 CFR 812.20(a):“A sponsor shall submit an application to FDA for aninvestigational device exemption (IDE)if the device is to be used in a clinical investigation to determine safety and effectiveness.”

21 CFR 812.2(b):Significant Risk device studies requireboth FDA and IRB approvalbefore initiation.

An IND (B) applies to drugs and biologics, not devices. Manufacturer permission (A, D) is not a regulatory requirement, although collaboration may be necessary. OHRP approval is not applicable.

Thus, the correct answer isC (IRB/IEC approval and an FDA IDE).

TheBelmont Report (1979)establishedthree key ethical principles:

Respect for Persons:Requires informed consent, recognition of autonomy, and protection of vulnerable individuals.

Beneficence:Obligation to maximize benefits and minimize harm.

Justice:Ensuring fairness in subject selection and distribution of research burdens/benefits.

Voluntary informed consent embodiesRespect for Persons, as subjects are given adequate information and freedom of choice. “Do no harm” (A) is a Hippocratic principle but not Belmont terminology.

Thus, the correct answer isB (Respect for persons).

The FDA has authority to imposeclinical holds and terminationson IND studies when subject safety is at risk.

21 CFR 312.44(b)(1):“The FDA may propose to terminate an IND if it finds that human subjects would be exposed to an unreasonable and significant risk of illness or injury.”

21 CFR 312.42(e):“If an IND is placed on clinical hold and the deficiencies have not been adequately addressed within 30 days, FDA may terminate the IND.”

Annual reports (A) are required but noncompliance usually results in clinical hold, not immediate termination. IRB approval delays (B) do not trigger termination; the site simply cannot begin. Investigators report safety data to sponsors, not directly to FDA (C).

Thus, the correct answer isD (The FDA issued a clinical hold, and 30 days have elapsed).

Sponsors are responsible for distributing safety updates across all investigators and the FDA.

21 CFR 312.55(b):“The sponsor shall promptly notify all participating investigators, and the FDA, of new significant adverse effects or risks with respect to the drug.”

Other responsibilities fall elsewhere:

Case histories (C) are maintained by investigators (21 CFR 312.62(b)).

Progress reports to IRBs (D) are the investigator’s duty (21 CFR 312.66).

Administration of investigational drug (A) is managed by the investigator at site level.

Thus, the correct answer isB (Ensuring FDA and investigators are promptly informed).

21 CFR Part 11governs the use of electronic records and electronic signatures in FDA-regulated research.

21 CFR 11.10(a):Requires “validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”

Validated systems ensure equivalency between electronic and paper records.

While access controls (D) are also mandated, they arepart of system validation, not the defining requirement. Printing/signing paper copies (A) is unnecessary under Part 11. Entry into an eCRF (C) is just one function, not sufficient for compliance.

Thus, the correct answer isB (Managed within a validated computer system).

Quality assurance (QA)is proactive and systematic, designed to prevent errors and ensure compliance.

ICH E6(R2) 1.46:Defines QA as “all those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements.”

Option A describes IRB responsibilities, Option C describesaudit, and Option D describes protocol approval processes. OnlyBaccurately matches the ICH definition of QA. QA is distinct fromquality control (QC), which is operational and focused on detection of issues during conduct.

Thus, the correct answer isB.